Abstract
BackgroundA rotator cuff tear is a common disabling shoulder problem. Symptoms include pain, weakness, lack of shoulder mobility and sleep disturbance. Many patients require surgery to repair the tear; however, there is a high failure rate. There is a pressing need to improve the outcome of rotator cuff surgery and the use of patch augmentation to provide support to the healing process and improve patient outcomes holds new promise. Patches have been made using different materials (e.g. human/animal skin or intestine tissue, and completely synthetic materials) and processes (e.g. woven or a mesh). However, clinical evidence on their use is limited. The aim of the patch-augmented rotator cuff surgery (PARCS) feasibility study is to determine, using a mixed method approach, the design of a definitive randomised trial assessing the effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible.MethodsThe objectives of this six-stage mixed methods feasibility study are to determine current practice, evidence and views about patch use; achieve consensus on the design of a randomised trial to evaluate patch-augmented rotator cuff surgery; and assess the acceptability and feasibility of the proposed design. The six stages will involve a systematic review of clinical evidence, two surveys of surgeons, focus groups and interviews with stakeholders, a Delphi study and a consensus meeting. The various stakeholders (including patients, surgeons, and representatives from industry, the NHS and regulatory bodies) will be involved across the six stages.DiscussionThe PARCS feasibility study will inform the feasibility and acceptability of a randomised trial of the effectiveness and cost-effectiveness of a patch-augmented rotator cuff surgery. Consensus opinion on the basic design of a randomised trial will be sought.Trial registrationNot applicable.
Highlights
A rotator cuff tear is a common disabling shoulder problem
Rotator cuff tears are a relatively common problem, and the number of operations to repair them is likely to grow in developed countries over the foreseeable future as the population ages
The augmentation of the operation with a patch seems promising with some evidence of clinical benefit
Summary
A rotator cuff tear is a common disabling shoulder problem. Symptoms include pain, weakness, lack of shoulder mobility and sleep disturbance. Clinical problem Rotator cuff conditions relate to the tendons and muscles surrounding the shoulder joint. They account for up to 70% of shoulder pain problems and are the third most prevalent musculoskeletal disorder after lower back and neck pain [1, 2]. Initial management is conservative and includes rest with simple pain management through paracetamol and non-steroidal anti-inflammatory drugs, often followed by an injection of corticosteroid into the subacromial space between the acromion process of the shoulder blade and the rotator cuff tendons below [3]. 40% of patients will continue to experience pain despite conservative management [5, 6], and many will require surgery to repair a tear in the rotator cuff
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